An interventional study of Exercise challenge in the cold chamber (ECC) and mRNA profile in Exercise Induced Asthma and House Dust Mite Allergy, sponsored by Johann Wolfgang Goethe University Hospital. Status unknown at 1 site in Germany. Open to participants aged 12 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-03.
Sponsored by Johann Wolfgang Goethe University Hospital · Not applicable, Interventional, and Diagnostic
The purpose of this study is to investigate the micro ribonucleic acid (mRNA) profiles of patients with EIA without allergic sensitization and EIA with house dust mite sensitization compared to that of healthy controls.
Patients with known EIA are periodically reexamined by medical history, clinical examination, bodyplethysmography, spirometry, exhaled nitric oxide (eNO), skin prick test, methacholin challenge test and exercise-challenge in a cold-chamber at 2-4°C (ECC). Additionally the investigators gathers the questionnaires: Asthma Control Test (ACT) and Dyspnoe Index (DI).
Besides these standard procedures the investigators want to investigate the micro-RNA profiles in two EIA subgroups: EIA with house-dust allergy (n = 24) and EIA without house-dust allergy (n = 24).
Both groups are characterized by different eNO levels. The patients with EIA and house-dust allergy should have an eNO > 30 ppb, the patients with EIA without house-dust allergy an eNO \< 20 ppb.
The micro-RNA profiles of the both EIA subgroups will be compared the micro RNA profiles of 20 healthy controls .
Therefore blood will be taken (for a complete blood count and micro RNA analysis) at three points of time: before ECC, directly after ECC and after 24 hours ± 4 hours after ECC.
52 studies on the registry are indexed under Asthma, Exercise-Induced; 3 are open to participants now.
This study's planned enrollment of 68 is above the median of 47 across 40 interventional studies indexed under Asthma, Exercise-Induced.
Browse Asthma, Exercise-Induced studies →Johann Wolfgang Goethe University Hospital is the lead sponsor of 160 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For EIA patients
Inclusion Criteria:
Exclusion Criteria:
For healthy controls
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with EIA and house-dust mite allergy and an eNO \> 30 ppb
Diagnostic Test: Exercise challenge in the cold chamber (ECC) · Diagnostic Test: mRNA profile · Diagnostic Test: standard diagnostic
Patients with EIA without allergic sensitization and an eNO \< 20 ppb
Diagnostic Test: Exercise challenge in the cold chamber (ECC) · Diagnostic Test: mRNA profile · Diagnostic Test: standard diagnostic
Healthy controls without allergic sensitization or known asthma
Diagnostic Test: mRNA profile · Diagnostic Test: standard diagnostic
Exercise challenge (defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber. Gradient: 10%, temperature 2-4°C. After the exercise challenge controlling bodyplethysmography and spirometry after 5, 10, 15 and 30 minutes. A positive reaction is a decrease of ≥ 10% of FEV1 in comparison to the initial value.
Blood taking with full blood exam and PAXgene tube for investigation oft the micro RNA profiles. The PAXgene Blood RNA kit insulates total RNA inclusive miRNA and small RNA which are centrifugated, pelletised, washed and incubated to detach proteins. For mapping the particular miRNA there will be generated libraries with specifical codes to match the analysis to the original probe. Next generation sequencing will be performed by MISeq REagent Kit v3 and the analysis oft the different expressions in the R Version 3.2.3. The divergent expressions will be refurbished by computer and databased.
bodyplethysmography, spirometry, exhaled NO, skin prick test, asthma control test (ACT)
Dysregulation of miRNA-146
The primary endpoint is the dysregulation of miRNA-146 in comparison to the control group and within the subgroups which play an determined role in the bronchial inflammation. Therefore the total RNA, including miRNA, will be isolated using the PAXgene Blood miRNA Kit (Qiagen, Hilden, Germany). Concentration of RNA will be assessed using Nanodrop Lite spectrometry (Thermo Scientific, Dreieich, Germany). MiRNA libraries are generated with the QIAseq miRNA Library Kit (Qiagen, Hilden, Germany). Next generation sequencing (NGS) will be performed with the MiSeq Reagent Kit v3, the PhiX Sequencing Control v3 and the MiSeq™ Desktop Sequencer (all Illumina Inc., San Diego, CA, USA). Differential expression analysis will be performed in RStudio 1.2.1335 (https://cran.r-project.org/). False discovery rate correction will be applied and miRNAs are considered to be differentially expressed with p \< 0.05.
Time frame: 1 Year
Dysregulation miRNAs affecting Th2 mediated bronchial inflammation (miRNA-126, miRNA-21, miRNA-145, let7-mimic)
Dysregulation of other miRNAs affecting the Th2 mediated bronchial inflammation (miRNA-126, miRNA-21, miRNA-145, let7-mimic) and compare to the control group. MiRNA preparation and measurement processes are described in Outcome 1.
Time frame: 1 Year
Cange of eNO
Change of eNO after ECC in the EIA subgroups compared to the healthy controls
Time frame: 1 Year
Change of leucocytes and neutrophile granulocytes
Change of leucocytes and neutrophile granulocytes after ECC in the EIA subgroups compared to the healthy controls
Time frame: 1 Year
FEV1-decrease in ECC
Comparison of the FEV1-decrease in ECC with significant dysregulated miRNA in the EIA subgroups compared to the healthy controls
Time frame: 1 Year
Comparison eNO with significant dysregulated miRNA
Comparison of the initial value of exhaled NO with significant dysregulated miRNA in the EIA subgroups compared to the healthy controls
Time frame: 1 Year
Comparison of change of leucocytes and neutrophile granulocytes with significant dysregulated miRNA
Comparison of the increase of leucocytes and neutrophile granulocytes after ECC significant dysregulated miRNA in the EIA subgroups compared to the healthy controls
Time frame: 1 Year
Comparison of ACT with significant dysregulated miRNA
Comparison of the score in ACT with significant dysregulated miRNA in the EIA subgroups compared to the healthy controls
Time frame: 1 Year
Comparison of DI with significant dysregulated miRNA
Comparison of the scoresin DI with significant dysregulated miRNA in the EIA subgroups compared to the healthy controls
Time frame: 1 Year
Plan to share: No
Started Aug 2021 (actual). Primary completion is estimated for Aug 2022, 12 months after the start.
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